A composition containing polygonatum, a preparation method thereof and a use thereof for preventing and treating sarcopenia

Abstract

The application discloses a composition containing Rhizoma Polygonati for preventing and / or treating sarcopenia, which comprises Rhizoma Polygonati, Angelica sinensis, Radix Codonopsis, Radix Rehmanniae Preparata, Cistanche deserticola, Lycium barbarum, Poria cocos and Crataegus pinnatifida Bunge; wherein the mass ratio of the Rhizoma Polygonati, the Angelica sinensis, the Radix Codonopsis, the Radix Rehmanniae Preparata, the Cistanche deserticola, the Lycium barbarum, the Poria cocos and the Crataegus pinnatifida Bunge is (6-20):(3-15):(6-20):(7-15):(3-11):(10-15):(6-14):(3-11). The composition of the application can effectively improve the muscle strength, muscle mass, exercise endurance, grip strength, coordination function of model animals, and improve the muscle structure and fibrosis state, and has good anti-sarcopenia effect and clinical application prospect.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, specifically to a composition containing Polygonatum sibiricum, its preparation method, and its use in preventing and treating sarcopenia. Background Technology

[0002] Sarcopenia, also known as muscle loss, is an age-related, progressive syndrome characterized by a decrease in overall muscle mass, strength, and / or physical function. With the increasing global aging trend, the incidence of sarcopenia is rising annually. It is estimated that approximately 50 million people worldwide currently suffer from sarcopenia, and this number is projected to exceed 500 million by 2050. Sarcopenia has an insidious onset and can cause or worsen dysfunction in multiple systems of the body, increasing the risk of falls, fractures, frailty, and even death in the elderly. It severely impairs the quality of life and health of older adults, placing a heavy medical burden on patients' families and society. Therefore, effective prevention and treatment of sarcopenia has become an urgent public health issue.

[0003] Against the backdrop of an accelerating global population aging process, sarcopenia has become a core challenge affecting the quality of life and healthy lifespan of the population. Recent epidemiological surveys show that the prevalence of sarcopenia among people aged 60 and above in my country is 5.7% to 23.9%. The occurrence of sarcopenia increases the risk of fall-related injuries by 85%, and in severe cases, the risk of hospitalization increases by 31%, and medical expenses increase by 4%.

[0004] Currently, interventions for sarcopenia are limited. Resistance training and nutritional support are the mainstream strategies, but they still suffer from difficulties in implementation and significant individual variability in efficacy. Furthermore, there is no FDA-approved drug specifically for sarcopenia. While commonly used drugs such as vitamin D, testosterone, and growth hormones have shown some clinical efficacy, their mechanisms are unclear and they pose risks such as cardiovascular complications and masculinizing side effects. Due to the complex pathogenesis of sarcopenia, many single-target or single-factor treatments in modern medicine often fail to achieve ideal results. Therefore, given its complex pathogenesis, comprehensive intervention remains a significant challenge. Unlike Western medicine, Traditional Chinese Medicine (TCM) has a unique understanding of sarcopenia. TCM emphasizes holistic diagnosis and treatment, highlighting the synergistic effects of multiple components, targets, and pathways, giving it a significant advantage in intervening in complex diseases. Therefore, identifying potential candidate drugs for treating sarcopenia from TCM formulas is of great value.

[0005] Sarcopenia belongs to the categories of "flaccidity syndrome" and "consumptive disease" in traditional Chinese medicine (TCM). The corresponding TCM disease names include "flaccidity syndrome", "flaccidity with difficulty in walking", "consumptive disease", "deficiency impairment", and "extreme muscular debility", etc. The onset of this disease is closely related to the dysfunction of the spleen, kidney, and liver. Multiple zang-fu organs often need to work together for overall improvement. Tang Rongchuan's *Treatise on Blood Syndromes* states: "At the beginning of fetal development, the congenital endowment gives rise to the acquired constitution. After a person is born and grows, the acquired constitution nourishes the congenital endowment." *Classic of Difficult Issues - Difficult Issue 24* records: "When the muscles and bones are not in harmony, the muscles become flaccid and shrink; when the muscles become flaccid and shrink, the teeth grow long and become withered, and the hair loses its luster; those without luster indicate that the bones are already dying." The spleen is the foundation of the acquired constitution, responsible for transporting and transforming the essence of water and grains, providing nutrition for the muscles; the kidney is the foundation of the congenital endowment, responsible for bones, generating marrow, and storing essence. When the spleen and kidney coordinate and the acquired and congenital endowments mutually support each other, the muscles and bones are in harmony, the bones are strong, and the muscles are plump. On the contrary, as people age, the heavenly essence dries up, the kidney essence is insufficient, the spleen and stomach are malnourished, then the bones become withered and brittle, the muscles have nothing to attach to, and then become flaccid and weak, with both the muscles and bones damaged. The liver governs the tendons and vessels, with a yin body and a yang function, and is responsible for dredging and regulating; when the liver blood is sufficient, it nourishes the tendons, the tendons are strong, and can play the role of binding the muscles and bones and facilitating joint movement. Insufficient liver blood leads to malnourishment of the tendons and vessels. The prevention and treatment of sarcopenia from the perspective of bone health emphasizes more on the coordinated development of muscles and bones, advocating that "the muscles serve the bones, and both muscles and bones are equally important". Through overall regulation and multi-target intervention, comprehensive management of "prevention, diagnosis, treatment, rehabilitation, and nourishment" is implemented for the disease. Clinically, it usually takes strengthening the spleen and tonifying the kidney as the core, supplementing qi and blood and filling the marrow as the supplement, taking into account pathological products such as dampness, phlegm turbidity, and stasis of blood, and treating based on syndrome differentiation, addressing both the symptoms and the root causes to comprehensively improve the health of the body.

[0006] In the prior art, there is no disclosure of a composition containing polygonatum, its preparation method, and its use in preventing and treating sarcopenia as claimed in the present invention. Summary of the Invention

[0007] Based on this, the present invention provides a composition containing polygonatum for preventing and / or treating sarcopenia, which composition comprises polygonatum, angelica sinensis, codonopsis pilosula, rehmannia glutinosa, cistanche deserticola, wolfberry fruit, poria cocos, and hawthorn;

[0008] Among them, the mass ratio of the polygonatum, the angelica sinensis, the codonopsis pilosula, the rehmannia glutinosa, the cistanche deserticola, the wolfberry fruit, the poria cocos, and the hawthorn is (6 - 20):(3 - 15):(6 - 20):(7 - 15):(3 - 11):(10 - 15):(6 - 14):(3 - 11).

[0009] Furthermore, the mass ratio of the following ingredients is (8-18):(4-14):(8-18):(7.5-14):(4-10.5):(8-14):(7-14):(4-10.5). Further, the mass ratio of the following ingredients is (9-16):(5-13):(9-16):(8-13):(5-10):(11-13):(8-13):(5-10). Further, the mass ratio of the following ingredients is approximately (10-15):(6-12):(10-15):(9-12):(6-9):approximately 12:(9-12):(6-9). Further, the mass ratio of the following ingredients is approximately 10:approximately 6:approximately 15:approximately 9:approximately 9:approximately 12:approximately 12:approximately 9. Further, the mass ratio of the following ingredients is approximately 15:approximately 6:approximately 10:approximately 9:approximately 9:approximately 12:approximately 12:approximately 9:approximately 6. Further, the mass ratio of the Polygonatum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida is approximately 15:12:15:12:6:12:9:9. Further, the mass of the Polygonatum is 9–16 g, for example, about 10 g or about 15 g. Further, the mass of the Angelica sinensis is 5–13 g, for example, about 6 g or about 12 g. Further, the mass of the Codonopsis pilosula is 9–16 g, for example, about 10 g or about 15 g. Further, the mass of the Rehmannia glutinosa is 8–13 g, for example, about 9 g or about 12 g. Further, the mass of the Cistanche deserticola is 5–10 g, for example, about 6 g or about 9 g. Further, the mass of the Lycium barbarum is 11–13 g, for example, about 12 g. Furthermore, the weight of the Poria cocos is 8–13g, for example, about 9g or about 12g. Furthermore, the weight of the hawthorn is 5–10g, for example, about 6g or about 9g.

[0010] According to another aspect of the present invention, a method for preparing the above-mentioned composition is provided, the method comprising the following steps: (1) weighing appropriate amounts of Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos and Crataegus pinnatifida, adding water for the first time, soaking and then heating to extract, boiling and continuing to decoct for a period of time, filtering to obtain a first filtrate and a first dregs; (2) adding water to the first dregs for the second time, heating to extract, boiling and continuing to decoct for a period of time, filtering to obtain a second filtrate; and (3) combining the first filtrate and the second filtrate, concentrating to a concentrated solution and then drying to obtain the composition.

[0011] Further, the water is distilled water or ultrapure water. Further, the soaking time is 0.5 to 2 hours. Further, the ratio of the mass of the water added in the first addition to the total mass of the Polygonatum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida is 1 to 20, for example, about 10. Further, the ratio of the mass of the water added in the second addition to the mass of the first dregs or the total mass of the Polygonatum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida is 1 to 20, for example, about 8. Further, in step (1), the boiling and subsequent simmering time is 0.5 to 2 hours, for example, about 1 hour. Further, in step (2), the boiling and subsequent simmering time is 0.3 to 1 hour, for example, about 0.5 hours. Further, the drying temperature is 50 to 70°C, for example, about 60°C.

[0012] According to another aspect of the invention, a pharmaceutical formulation is provided comprising the above-described composition and one or more pharmaceutically acceptable excipients. Further, the excipients are selected from one or more of the following: diluents, wetting agents, binders, disintegrants, inclusion agents, flavoring agents, sustained-release agents, flow aids, lubricants, dispersants, plasticizers, light-blocking agents, and antioxidants. Further, the dosage form of the pharmaceutical formulation is a powder, tablet, pellet, capsule, film, lozenge, granule, injection, or oral liquid. Further, the pharmaceutical formulation further comprises one or more other drugs for the prevention and / or treatment of sarcopenia. Further, the other drugs are selected from one or more of the following: testosterone, selective androgen receptor modulators, growth hormone, ghrelin, and myostatin inhibitors.

[0013] According to another aspect of the present invention, there is provided the use of the above-described composition or pharmaceutical preparation in the preparation of a medicament for the prevention and / or treatment of sarcopenia. Further, the composition or preparation prevents and / or treats sarcopenia through one or more of the following mechanisms: increasing MyHC gene mRNA expression levels, increasing body weight, increasing muscle mass, improving muscle motor function, and improving muscle pathological abnormalities. Further, the muscle mass includes quadriceps femoris mass, gastrocnemius mass, tibialis anterior mass, extensor digitorum longus mass, and / or soleus mass. Further, the improvement in muscle motor function includes increased physical endurance, increased muscle strength, and / or improved balance and coordination. Further, the muscle pathological abnormalities include muscle fiber atrophy and / or muscle fibrosis.

[0014] The beneficial effects of this invention are:

[0015] The composition of the present invention can effectively improve muscle strength, muscle mass, exercise endurance, grip strength, and coordination in model animals, and improve muscle structure and fibrosis status, showing good anti-sarcopenia effects and clinical application prospects. Attached Figure Description

[0016] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without exceeding the scope of protection claimed by the present invention.

[0017] Figure 1 This is a schematic diagram showing the regulatory effects of different drug combinations on MyHC expression according to the present invention.

[0018] Figure 2 This is a schematic diagram showing the changes in mouse body weight in Example 2 of the efficacy of the present invention.

[0019] Figure 3 This is a schematic diagram of the skeletal muscle in Example 2 of the efficacy of the present invention.

[0020] Figure 4 This is a schematic diagram of skeletal muscle mass in Example 2 of the efficacy of the present invention.

[0021] Figure 5 This is a schematic diagram of the gripping force test results of Example 2 of the efficacy of the present invention.

[0022] Figure 6 This is a schematic diagram of the exhaustion running distance results in Example 2 of the efficacy of the present invention.

[0023] Figure 7 This is a schematic diagram of the rotator test results of Example 2 of the efficacy of the present invention.

[0024] Figure 8 This is a schematic diagram of the grid suspension experiment results of the second efficacy embodiment of the present invention.

[0025] Figure 9 This is a schematic diagram of the HE staining results of Example 2 of the efficacy of the present invention.

[0026] Figure 10 This is a schematic diagram of the Masson staining results for Example 2 of the efficacy of the present invention. Detailed Implementation

[0027] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0028] Unless otherwise stated, all technical and scientific terms and abbreviations used herein have the meanings commonly understood by one of ordinary skill in the field of this invention or the field of application of such terms. While any methods, conditions, substances, or materials similar to or equivalent to those disclosed herein may be used in the practice of this invention, preferred methods, conditions, substances, or materials are described herein.

[0029] This invention is intended to cover all options, variations, and equivalents that may be included in the field of prior art as defined in the claims. Those skilled in the art will recognize many similar or equivalent methods and substances described herein that can be applied in the practice of this invention. This invention is by no means limited to the description of methods and substances.

[0030] The singular forms “a,” “an,” and “the” used in the specification and appended claims include plural indicators unless the context clearly specifies otherwise.

[0031] In this invention, the term "comprising" and "including" are synonymous. The terms "comprising," "including," "having," "containing," or any other variations thereof as used herein are intended to cover a non-exclusive inclusion. For example, a composition, step, method, article, or apparatus that includes the listed elements is not necessarily limited to those elements, but may include other elements not expressly listed or elements inherent to such a composition, step, method, article, or apparatus.

[0032] As described in the background section, the prior art does not provide the composition containing Polygonatum sibiricum claimed in this invention, its preparation method, or its use in preventing and treating sarcopenia. To address the above-mentioned problems, this invention provides a composition containing Polygonatum sibiricum for the prevention and / or treatment of sarcopenia, comprising Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida;

[0033] The mass ratio of the following ingredients is (6-20): (3-15): (6-20): (7-15): (3-11): (10-15): (6-14): (3-11).

[0034] In this invention, when mass ratio, time, mass, ratio value, temperature, or other values ​​or parameters are expressed as ranges, preferred ranges, or a series of upper and lower preferred values, this should be understood as specifically disclosing all ranges formed by any pairing of any upper or preferred value with any lower or preferred value, regardless of whether the range is disclosed individually. For example, when the range “6–20” is disclosed, the described range should be interpreted as including ranges “6–20”, “6–16”, “6–12”, “6–8”, “8–20”, “8–16”, “8–12”, “12–20”, “12–16”, “16–20”, etc. When numerical ranges are described herein, unless otherwise stated, the range is intended to include its endpoints and all integers and fractions within that range.

[0035] The composition of this invention uses Polygonatum sibiricum as the principal ingredient. Polygonatum sibiricum is sweet and neutral in nature, and enters the spleen, lung, and kidney meridians. Its functions include tonifying qi and nourishing yin, strengthening the spleen and moistening the lungs, and benefiting the kidneys and replenishing essence. Its uniqueness lies in simultaneously tonifying the qi and yin of the lungs, spleen, and kidneys, making it a key ingredient for nourishing the internal organs, replenishing qi and blood, and strengthening muscles and bones. This lays the foundation for the entire formula's core principle of tonifying qi and nourishing yin, strengthening the spleen and benefiting the kidneys to combat the pathogenesis of sarcopenia—qi and blood deficiency, impaired distribution of essence, and malnourishment of muscles and bones—effectively improving muscle weakness and fatigue. Codonopsis pilosula, Rehmannia glutinosa, and Angelica sinensis are the assistant ingredients. Codonopsis pilosula is sweet and neutral in nature, and enters the spleen and lung meridians. It excels at strengthening the spleen and lungs, nourishing blood and generating fluids, assisting Polygonatum sibiricum in greatly tonifying the middle qi, strengthening the spleen and stomach's digestive function, promoting the generation of qi and blood, and providing an energy foundation for muscles. Rehmannia glutinosa (Shu Di Huang) is sweet and slightly warm in nature, entering the liver and kidney meridians. It is specifically effective in nourishing blood and yin, replenishing essence and marrow, and strongly replenishing liver and kidney essence and blood. It is key to strengthening muscles and bones and improving muscle atrophy and lower back and knee weakness caused by deficiency of essence and marrow. Angelica sinensis (Dang Gui) is sweet, pungent, and warm in nature, entering the liver, heart, and spleen meridians. It can both nourish and invigorate blood, regulate menstruation and relieve pain, and moisten the intestines and promote bowel movements. Its blood-invigorating effect promotes smooth blood flow, nourishes tendons and muscles, and relieves numbness and limited mobility of limbs caused by blood deficiency and blood stasis. These three herbs complement each other: Codonopsis pilosula (Dang Shen) primarily replenishes qi, Rehmannia glutinosa primarily nourishes yin, blood, and essence, and Angelica sinensis primarily replenishes and invigorates blood. Together, they strongly support the principal herb, Polygonatum sibiricum (Huang Jing), achieving the core goal of replenishing qi and nourishing blood, providing sufficient qi, blood, and essence for the muscles. Cistanche deserticola (Rou Cong Rong), Lycium barbarum (Gou Qi Zi), and Poria cocos (Fu Ling) serve as adjuvant herbs. Cistanche deserticola is sweet, salty, and warm in nature, and enters the kidney and large intestine meridians. It tonifies kidney yang, benefits essence and blood, and moistens the intestines to relieve constipation. It warms kidney yang to aid in the generation of essence and blood, strengthens muscles and bones, and assists Angelica sinensis in moistening the intestines and relieving constipation, preventing stagnation caused by tonification. Lycium barbarum is sweet and neutral in nature, and enters the liver, kidney, and lung meridians. It nourishes the liver and kidneys, benefits essence and improves eyesight. Together with Rehmannia glutinosa, it synergistically nourishes the yin essence of the liver and kidneys, forming a dual yin-yang tonifying effect with Cistanche deserticola, consolidating the foundation and strengthening the body's foundation. Poria cocos is sweet, bland, and neutral in nature, and enters the heart, lung, spleen, and kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. Its spleen-strengthening effect assists Codonopsis pilosula and Polygonatum sibiricum in enhancing the spleen and stomach's ability to transform and transport the essence of food, preventing the internal generation of dampness and ensuring the smooth production of qi and blood; its calming effect helps improve fatigue; and its diuretic ability prevents tonifying drugs from causing dampness and hindering spleen function. The three herbs work together: Cistanche deserticola warms kidney yang, Lycium barbarum nourishes kidney yin, and Poria cocos strengthens the spleen and eliminates dampness. Together, they deepen the kidney-tonifying and spleen-strengthening effects, assisting the principal and assistant herbs in fully mobilizing bodily functions, improving symptoms such as lower back and knee weakness, fatigue, and poor appetite, and preventing stagnation caused by the tonifying herbs. Hawthorn, as the guiding herb, is sour, sweet, and slightly warm in nature, and enters the spleen, stomach, and liver meridians. It has the effects of promoting digestion and strengthening the stomach, regulating qi and dispersing blood stasis, and resolving turbidity and lowering lipids. It can harmonize the other herbs, guiding the medicinal power to the limbs, bones, and muscles; it can also regulate qi and disperse blood stasis, assisting Angelica sinensis in activating blood, slightly clearing the meridians, improving local microcirculation, and promoting the distribution of qi, blood, and essence to muscle tissue; at the same time, it promotes digestion and strengthens the stomach, resolves turbidity and lowers lipids, assists Codonopsis pilosula and Poria cocos in strengthening the spleen and promoting digestion, prevents tonifying herbs such as Polygonatum sibiricum and Rehmannia glutinosa from causing stagnation in the stomach, and resolves phlegm and lipids, ensuring the effective absorption and transformation of the tonifying power, so that the whole formula is tonifying without stagnation, and active and orderly. The combined effects of the various herbs closely adhere to the core functions of "tonifying qi and blood, strengthening the spleen and benefiting the kidneys".This formula comprehensively replenishes Qi and blood to nourish muscles, strengthens the spleen and kidneys to strengthen the body's foundation, and also promotes blood circulation, eliminates turbidity and prevents stagnation. It is nourishing without being greasy, moisturizing without causing stagnation, and invigorating without harming. It can effectively improve the core symptoms of sarcopenia, such as muscle wasting, limb fatigue and weakness, soreness of the waist and knees, fatigue and poor appetite, and decreased activity level, and promote the recovery and growth of muscle tissue function.

[0036] In a preferred embodiment, the mass ratio of the Polygonatum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida is (8-18):(4-14):(8-18):(7.5-14):(4-10.5):(8-14):(7-14):(4-10.5). In another preferred embodiment, the mass ratio of the Polygonatum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida is (9-16):(5-13):(9-16):(8-13):(5-10):(11-13):(8-13):(5-10). In a preferred embodiment, the mass ratio of the Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos and Crataegus pinnatifida is (10-15):(6-12):(10-15):(9-12):(6-9):approximately 12:(9-12):(6-9).

[0037] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 12" includes ±5% of 12, or from 11.4 to 12.6.

[0038] In a preferred embodiment, the mass ratio of the Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida is about 10: about 6: about 15: about 9: about 9: about 12: about 12: about 9.

[0039] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 10" includes ±5% of 10, or from 9.5 to 10.5; "about 6" includes ±5% of 6, or from 5.7 to 6.3; "about 15" includes ±5% of 15, or from 14.25 to 15.75; "about 9" includes ±5% of 9, or from 8.55 to 9.45; and "about 12" includes ±5% of 12, or from 11.4 to 12.6.

[0040] In a preferred embodiment, the mass ratio of the Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida is about 15: about 6: about 10: about 9: about 9: about 12: about 9: about 6.

[0041] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 15" includes ±5% of 15, or from 14.25 to 15.75; "about 6" includes ±5% of 6, or from 5.7 to 6.3; "about 10" includes ±5% of 10, or from 9.5 to 10.5; "about 9" includes ±5% of 9, or from 8.55 to 9.45; and "about 12" includes ±5% of 12, or from 11.4 to 12.6.

[0042] In a preferred embodiment, the mass ratio of the Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida is about 15: about 12: about 15: about 12: about 6: about 12: about 9: about 9.

[0043] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 15" includes ±5% of 15, or from 14.25 to 15.75; "about 12" includes ±5% of 12, or from 11.4 to 12.6; "about 6" includes ±5% of 6, or from 5.7 to 6.3; and "about 9" includes ±5% of 9, or from 8.55 to 9.45.

[0044] In a preferred embodiment, the mass of the Polygonatum is 9 to 16 g, for example, about 10 g or about 15 g.

[0045] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 10" includes ±5% of 10, or from 9.5 to 10.5; "about 15" includes ±5% of 15, or from 14.25 to 15.75.

[0046] In a preferred embodiment, the weight of the angelica is 5 to 13 g, for example, about 6 g or about 12 g.

[0047] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 6" includes ±5% of 6, or from 5.7 to 6.3; "about 12" includes ±5% of 12, or from 11.4 to 12.6.

[0048] In a preferred embodiment, the Codonopsis pilosula weighs 9 to 16 g, for example, about 10 g or about 15 g.

[0049] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 10" includes ±5% of 10, or from 9.5 to 10.5; "about 15" includes ±5% of 15, or from 14.25 to 15.75.

[0050] In a preferred embodiment, the weight of the prepared rehmannia root is 8 to 13 g, for example, about 9 g or about 12 g.

[0051] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 9" includes ±5% of 9, or from 8.55 to 9.45; "about 12" includes ±5% of 12, or from 11.4 to 12.6.

[0052] In a preferred embodiment, the mass of the Cistanche deserticola is 5-10g, for example, about 6g or about 9g.

[0053] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 6" includes ±5% of 6, or from 5.7 to 6.3; "about 9" includes ±5% of 9, or from 8.55 to 9.45.

[0054] In a preferred embodiment, the goji berries weigh 11-13g, for example, about 12g.

[0055] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 12" includes ±5% of 12, or from 11.4 to 12.6.

[0056] In a preferred embodiment, the weight of the Poria cocos is 8 to 13 g, for example, about 9 g or about 12 g.

[0057] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 9" includes ±5% of 9, or from 8.55 to 9.45; "about 12" includes ±5% of 12, or from 11.4 to 12.6.

[0058] In a preferred embodiment, the hawthorn weighs 5 to 10g, for example, about 6g or about 9g.

[0059] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 6" includes ±5% of 6, or from 5.7 to 6.3; "about 9" includes ±5% of 9, or from 8.55 to 9.45.

[0060] According to another aspect of the present invention, a method for preparing the above-described composition is provided, the method comprising the following steps:

[0061] (1) Weigh appropriate amounts of Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos and Crataegus pinnatifida. Add water for the first time, soak, heat and extract, boil and continue to decoct for a period of time, filter to obtain the first filtrate and the first dregs; (2) Add water to the first dregs for the second time, heat and extract, boil and continue to decoct for a period of time, filter to obtain the second filtrate; and (3) Combine the first filtrate and the second filtrate, concentrate to a concentrated solution and then dry to obtain the composition.

[0062] In a preferred embodiment, the water is distilled water or ultrapure water.

[0063] In a preferred embodiment, the soaking time is 0.5 to 2 hours.

[0064] In a preferred embodiment, the ratio between the mass of the water added in the first addition and the total mass of the Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos and Crataegus pinnatifida is 1 to 20, for example, about 10.

[0065] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 10" includes ±5% of 10, or from 9.5 to 10.5.

[0066] In a preferred embodiment, the ratio between the mass of the water added in the second addition and the mass of the first dregs or the total mass of the Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos and Crataegus pinnatifida is 1 to 20, for example, about 8.

[0067] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 8" includes ±5% of 8, or from 7.6 to 8.4.

[0068] In a preferred embodiment, in step (1), the boiling and simmering time is 0.5 to 2 hours, for example, about 1 hour.

[0069] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 1" includes ±5% of 1, or from 0.95 to 1.05.

[0070] In a preferred embodiment, in step (2), the boiling and simmering time is 0.3 to 1 hour, for example, about 0.5 hours.

[0071] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 0.5" includes ±5% of 0.5, or from 0.475 to 0.525.

[0072] In a preferred embodiment, the drying temperature is 50–70°C, for example, about 60°C.

[0073] In this invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 60" includes ±5% of 60, or from 57 to 63.

[0074] According to another aspect of the present invention, a method for preparing the above-mentioned composition is provided, the method comprising the following steps: taking appropriate amounts of Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos and Crataegus pinnatifida together, soaking in water for 0.5-2 hours, and then decocting twice consecutively. For the first decoction, add water equal to 10 times the total weight of the raw materials and decoct, filter to obtain the first decoction and residue, add water equal to 8 times the weight of the residue to the residue and decoct, filter and discard the residue to obtain the second decoction; finally, combine the filtrates obtained from the two decoctions and concentrate them, concentrate them into a concentrated liquid and dry them to obtain the desired traditional Chinese medicine composition.

[0075] According to another aspect of the invention, a pharmaceutical formulation is provided comprising the above-described composition and one or more pharmaceutically acceptable excipients. In a preferred embodiment, the excipients are selected from one or more of the following: diluents, wetting agents, binders, disintegrants, inclusion agents, flavoring agents, sustained-release agents, flow aids, lubricants, dispersants, plasticizers, light-blocking agents, and antioxidants. In a preferred embodiment, the pharmaceutical formulation is in the form of a powder, tablet, pellet, capsule, film, lozenge, granule, injection, or oral liquid. In a preferred embodiment, the pharmaceutical formulation further comprises one or more other drugs for the prevention and / or treatment of sarcopenia. In a preferred embodiment, the other drugs are selected from one or more of the following: testosterone, selective androgen receptor modulators, growth hormone, ghrelin, and myostatin inhibitors.

[0076] According to another aspect of the present invention, there is provided the use of the above-described composition or pharmaceutical preparation in the preparation of a medicament for the prevention and / or treatment of sarcopenia. In a preferred embodiment, the composition or preparation prevents and / or treats sarcopenia through one or more of the following mechanisms: increasing MyHC gene mRNA expression levels, increasing body weight, increasing muscle mass, improving muscle motor function, and improving muscle pathological abnormalities. In a preferred embodiment, the muscle mass includes quadriceps femoris mass, gastrocnemius mass, tibialis anterior mass, extensor digitorum longus mass, and / or soleus mass. In a preferred embodiment, the improvement in muscle motor function includes improved physical endurance, increased muscle strength, and / or improved balance and coordination. In a preferred embodiment, the muscle pathological abnormalities include muscle fiber atrophy and / or muscle fibrosis.

[0077] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Experimental methods in the following embodiments, unless otherwise specified, are generally performed under conventional conditions or conditions recommended by the manufacturer.

[0078] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as are familiar to those skilled in the art. Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to the methods of this invention. The preferred embodiments and materials described herein are for illustrative purposes only.

[0079] The features mentioned above in this invention, or the features mentioned in the embodiments, can be combined arbitrarily. All features disclosed in this patent specification can be used in any compositional form, and each feature disclosed in the specification can be replaced by any alternative feature that provides the same, equivalent, or similar purpose. Therefore, unless otherwise specified, the disclosed features are merely general examples of equivalent or similar features.

[0080] Example

[0081] Preparation Examples

[0082] 1. Experimental reagents

[0083] Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida were purchased from Wangjing Hospital of China Academy of Chinese Medical Sciences; the water was ultrapure water, and all other reagents were of analytical grade.

[0084] 2. Experiment Content

[0085] The preparation examples of this invention employ a uniform design experimental scheme for formulation optimization. Referring to the literature "Improved Application of Uniform Design in the Selection of Small Compound Traditional Chinese Medicine Formulas," a uniform design table was constructed (as shown in Table 1). Eight traditional Chinese medicines—Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida—were used as evaluation factors, with each factor having three different dosage levels (increasing in a gradient). By rationally arranging the various medicinal factors and their dosage levels using the uniform design table, 27 different combinations of traditional Chinese medicine formulas were finally constructed for subsequent optimization, screening, and efficacy verification.

[0086] Table 1 Uniform Experimental Design Scheme

[0087]

[0088]

[0089] Preparation Example 1

[0090] The medicinal materials used in this drug composition include 5g of Polygonatum sibiricum, 6g of Angelica sinensis, 5g of Codonopsis pilosula, 6g of Rehmannia glutinosa, 6g of Cistanche deserticola, 6g of Lycium barbarum, 9g of Poria cocos, and 6g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.49kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.392kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 1.

[0091] Preparation Example 2

[0092] The medicinal materials used in this drug composition include 5g of Polygonatum sibiricum, 6g of Angelica sinensis, 5g of Codonopsis pilosula, 9g of Rehmannia glutinosa, 9g of Cistanche deserticola, 12g of Lycium barbarum, 15g of Poria cocos, and 12g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.73kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.584kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 2.

[0093] Preparation Example 3

[0094] The medicinal materials used in this drug composition include 5g of Polygonatum sibiricum, 6g of Angelica sinensis, 5g of Codonopsis pilosula, 12g of Rehmannia glutinosa, 12g of Cistanche deserticola, 9g of Lycium barbarum, 12g of Poria cocos, and 9g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The water used for the first decoction is 0.7kg (10 times the total weight of the herbs), and the water used for the second decoction is 0.56kg (8 times the total weight of the herbs). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 3.

[0095] Preparation Example 4

[0096] The medicinal materials used in this drug composition include 5g of Polygonatum sibiricum, 9g of Angelica sinensis, 15g of Codonopsis pilosula, 6g of Rehmannia glutinosa, 12g of Cistanche deserticola, 12g of Lycium barbarum, 15g of Poria cocos, and 9g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used in the first decoction is 0.83kg (10 times the total mass of the medicinal materials), and the mass of water used in the second decoction is 0.664kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 4.

[0097] Preparation Example 5

[0098] The medicinal materials used in this drug composition include 5g of Polygonatum sibiricum, 9g of Angelica sinensis, 15g of Codonopsis pilosula, 9g of Rehmannia glutinosa, 6g of Cistanche deserticola, 9g of Lycium barbarum, 12g of Poria cocos, and 6g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.71kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.568kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 5.

[0099] Preparation Example 6

[0100] The medicinal materials used in this drug composition include 5g of Polygonatum sibiricum, 9g of Angelica sinensis, 15g of Codonopsis pilosula, 12g of Rehmannia glutinosa, 9g of Cistanche deserticola, 6g of Lycium barbarum, 9g of Poria cocos, and 12g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.77kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.616kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 6.

[0101] Preparation Example 7

[0102] The medicinal materials used in this drug composition include 5g of Polygonatum sibiricum, 12g of Angelica sinensis, 10g of Codonopsis pilosula, 6g of Rehmannia glutinosa, 9g of Cistanche deserticola, 9g of Lycium barbarum, 12g of Poria cocos, and 12g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The water used for the first decoction is 0.75kg (10 times the total weight of the herbs), and the water used for the second decoction is 0.6kg (8 times the total weight of the herbs). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 7.

[0103] Preparation Example 8

[0104] The medicinal materials used in this drug composition include 5g of Polygonatum sibiricum, 12g of Angelica sinensis, 10g of Codonopsis pilosula, 9g of Rehmannia glutinosa, 12g of Cistanche deserticola, 6g of Lycium barbarum, 9g of Poria cocos, and 9g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.72kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.576kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 8.

[0105] Preparation Example 9

[0106] The medicinal materials used in this drug composition include 5g of Polygonatum sibiricum, 12g of Angelica sinensis, 10g of Codonopsis pilosula, 12g of Rehmannia glutinosa, 6g of Cistanche deserticola, 12g of Lycium barbarum, 15g of Poria cocos, and 6g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.78kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.624kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 9.

[0107] Preparation Example 10

[0108] The medicinal materials used in this drug composition include 10g of Polygonatum sibiricum, 6g of Angelica sinensis, 15g of Codonopsis pilosula, 6g of Rehmannia glutinosa, 6g of Cistanche deserticola, 6g of Lycium barbarum, 15g of Poria cocos, and 12g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.76kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.608kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 10.

[0109] Preparation Example 11

[0110] The medicinal materials used in this drug composition include 10g of Polygonatum sibiricum, 6g of Angelica sinensis, 15g of Codonopsis pilosula, 9g of Rehmannia glutinosa, 9g of Cistanche deserticola, 12g of Lycium barbarum, 12g of Poria cocos, and 9g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.82kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.656kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 11.

[0111] Preparation Example Twelve

[0112] The medicinal materials used in this drug composition include 10g of Polygonatum sibiricum, 6g of Angelica sinensis, 15g of Codonopsis pilosula, 12g of Rehmannia glutinosa, 12g of Cistanche deserticola, 9g of Lycium barbarum, 9g of Poria cocos, and 6g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.79kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.632kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 12.

[0113] Preparation Example Thirteen

[0114] The medicinal materials used in this drug composition include 10g of Polygonatum sibiricum, 9g of Angelica sinensis, 10g of Codonopsis pilosula, 6g of Rehmannia glutinosa, 12g of Cistanche deserticola, 12g of Lycium barbarum, 12g of Poria cocos, and 6g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.77kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.616kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 13.

[0115] Preparation Example Fourteen

[0116] The medicinal materials used in this drug composition include 10g of Polygonatum sibiricum, 9g of Angelica sinensis, 10g of Codonopsis pilosula, 9g of Rehmannia glutinosa, 6g of Cistanche deserticola, 9g of Lycium barbarum, 9g of Poria cocos, and 12g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.74kg (10 times the total mass of the herbs), and the mass of water used for the second decoction is 0.592kg (8 times the total mass of the herbs). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 14.

[0117] Preparation Example 15

[0118] The medicinal materials used in this drug composition include 10g of Polygonatum sibiricum, 9g of Angelica sinensis, 10g of Codonopsis pilosula, 12g of Rehmannia glutinosa, 9g of Cistanche deserticola, 6g of Lycium barbarum, 15g of Poria cocos, and 9g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.8kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.64kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 15.

[0119] Preparation Example Sixteen

[0120] The medicinal materials used in this drug composition include 10g of Polygonatum sibiricum, 12g of Angelica sinensis, 5g of Codonopsis pilosula, 6g of Rehmannia glutinosa, 9g of Cistanche deserticola, 9g of Lycium barbarum, 9g of Poria cocos, and 9g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.69kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.552kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 16.

[0121] Preparation Example 17

[0122] The medicinal materials used in this drug composition include 10g of Polygonatum sibiricum, 12g of Angelica sinensis, 5g of Codonopsis pilosula, 9g of Rehmannia glutinosa, 12g of Cistanche deserticola, 6g of Lycium barbarum, 15g of Poria cocos, and 6g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The water used for the first decoction is 0.75kg (10 times the total weight of the herbs), and the water used for the second decoction is 0.6kg (8 times the total weight of the herbs). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 17.

[0123] Preparation Example 18

[0124] The medicinal materials used in this drug composition include 10g of Polygonatum sibiricum, 12g of Angelica sinensis, 5g of Codonopsis pilosula, 12g of Rehmannia glutinosa, 6g of Cistanche deserticola, 12g of Lycium barbarum, 12g of Poria cocos, and 12g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.81kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.648kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 18.

[0125] Preparation Example 19

[0126] The medicinal materials used in this drug composition include 15g of Polygonatum sibiricum, 6g of Angelica sinensis, 10g of Codonopsis pilosula, 6g of Rehmannia glutinosa, 6g of Cistanche deserticola, 6g of Lycium barbarum, 12g of Poria cocos, and 9g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The water used for the first decoction is 0.7kg (10 times the total weight of the herbs), and the water used for the second decoction is 0.56kg (8 times the total weight of the herbs). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 19.

[0127] Preparation Example 20

[0128] The medicinal materials used in this drug composition include 15g of Polygonatum sibiricum, 6g of Angelica sinensis, 10g of Codonopsis pilosula, 9g of Rehmannia glutinosa, 9g of Cistanche deserticola, 12g of Lycium barbarum, 9g of Poria cocos, and 6g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.76kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.608kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 20.

[0129] Preparation Example 21

[0130] The medicinal materials used in this drug composition include 15g of Polygonatum sibiricum, 6g of Angelica sinensis, 10g of Codonopsis pilosula, 12g of Rehmannia glutinosa, 12g of Cistanche deserticola, 9g of Lycium barbarum, 15g of Poria cocos, and 12g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used in the first decoction is 0.91kg (10 times the total mass of the medicinal materials), and the mass of water used in the second decoction is 0.728kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 21.

[0131] Preparation Example 22

[0132] The medicinal materials used in this drug composition include 15g of Polygonatum sibiricum, 9g of Angelica sinensis, 5g of Codonopsis pilosula, 6g of Rehmannia glutinosa, 12g of Cistanche deserticola, 12g of Lycium barbarum, 9g of Poria cocos, and 12g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.8kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.64kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 22.

[0133] Preparation Example 23

[0134] The medicinal materials used in this drug composition include 15g of Polygonatum sibiricum, 9g of Angelica sinensis, 5g of Codonopsis pilosula, 9g of Rehmannia glutinosa, 6g of Cistanche deserticola, 9g of Lycium barbarum, 15g of Poria cocos, and 9g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used in the first decoction is 0.77kg (10 times the total mass of the medicinal materials), and the mass of water used in the second decoction is 0.616kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 23.

[0135] Preparation Example 24

[0136] The medicinal materials used in this drug composition include 15g of Polygonatum sibiricum, 9g of Angelica sinensis, 5g of Codonopsis pilosula, 12g of Rehmannia glutinosa, 9g of Cistanche deserticola, 6g of Lycium barbarum, 12g of Poria cocos, and 6g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.74kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.592kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 24.

[0137] Preparation Example 25

[0138] The medicinal materials used in this drug composition include 15g of Polygonatum sibiricum, 12g of Angelica sinensis, 15g of Codonopsis pilosula, 6g of Rehmannia glutinosa, 9g of Cistanche deserticola, 9g of Lycium barbarum, 15g of Poria cocos, and 6g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used in the first decoction is 0.87kg (10 times the total mass of the medicinal materials), and the mass of water used in the second decoction is 0.696kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 25.

[0139] Preparation Example 26

[0140] The medicinal materials used in this drug composition include 15g of Polygonatum sibiricum, 12g of Angelica sinensis, 15g of Codonopsis pilosula, 9g of Rehmannia glutinosa, 12g of Cistanche deserticola, 6g of Lycium barbarum, 12g of Poria cocos, and 12g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.93kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.744kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 26.

[0141] Preparation Example 27

[0142] The medicinal materials used in this drug composition include 15g of Polygonatum sibiricum, 12g of Angelica sinensis, 15g of Codonopsis pilosula, 12g of Rehmannia glutinosa, 6g of Cistanche deserticola, 12g of Lycium barbarum, 9g of Poria cocos, and 9g of Crataegus pinnatifida. The herbs are decocted twice with water. The first decoction is decocted for 1 hour from the time of boiling, and the second for 0.5 hours. The mass of water used for the first decoction is 0.9kg (10 times the total mass of the medicinal materials), and the mass of water used for the second decoction is 0.72kg (8 times the total mass of the medicinal materials). The decoction is concentrated and dried at 60℃ to obtain the drug composition of group 27.

[0143] Pharmacological Examples

[0144] Example 1 of efficacy

[0145] 1. Experimental Materials

[0146] 1.1 Laboratory Animals

[0147] Healthy SPF-grade SD rats (weighing 200–250 g) were purchased from Spiford (Beijing) Biotechnology Co., Ltd. The rats were housed in an SPF-grade animal facility at a temperature maintained at (24±1)℃, relative humidity at 50%–70%, and a 12-hour light-dark cycle. All experimental procedures were strictly conducted in accordance with animal ethics regulations.

[0148] 1.2 Experimental Drugs

[0149] The drugs used in the experiment were the traditional Chinese medicine compositions prepared in Examples 1 to 27. The traditional Chinese medicine materials used included: Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida.

[0150] 2. Experimental Methods

[0151] 2.1 Preparation of drug-containing serum

[0152] SD rats were randomly divided into 28 groups (27 groups of drug-containing serum and 5 rats each of the blank control group, for a total of 140 rats). Each group of rats in the drug-containing serum group was administered the corresponding Chinese herbal medicine compositions from Examples 1-27 via gavage at the clinically equivalent human dose, once daily for 7 consecutive days. Rats were fasted for 12 hours before the last administration but allowed free access to water. 0.5–3 hours after the last administration, rats were anesthetized and blood was collected via the abdominal aorta. The collected blood was allowed to stand for 30 minutes and then centrifuged at 3000 rpm for 15 minutes at 4°C to separate the serum. The obtained serum was inactivated by water bath at 56°C for 30 minutes, aliquoted, and stored at -20°C or -80°C for later use, avoiding repeated freeze-thaw cycles.

[0153] 2.2 Cell Experiments

[0154] The C2C12 mouse skeletal muscle cell line was used as the experimental model. Cells were cultured in complete medium, and after reaching 80% confluence, the medium was replaced with 2% horse serum for differentiation. Five days after induction of differentiation, cells were treated with D-galactose (20 g / L) combined with drug-containing serum for 48 hours. A model group, a blank serum group, and 27 drug-containing serum treatment groups were set up.

[0155] 2.3 Indicator Testing

[0156] After treatment, the expression level of the muscle-related marker gene (MyHC) was detected by real-time quantitative PCR. Total RNA was extracted from cells using the Trizol method, and its purity (A260 / A280 = 1.8–2.1) and concentration were determined. cDNA was synthesized according to the kit. The upstream primer sequence for the MyHC gene was 5'-ATGGAGGAGGAGGAGGAGGA-3', and the downstream primer sequence was 5'-TCAGCTGCTGCTGCTGCTGC-3'. The upstream primer sequence for the internal reference gene β-actin was 5'-CTGAACGTGAAATTGTCCGAGA-3', and the downstream primer sequence was 5'-TTGCCAATGGTGATGACCTG-3'. The reaction system consisted of 20 μL (containing 2 μL of cDNA, 0.5 μM each of upstream and downstream primers, and 10 μL of SYBR Green Mix); the reaction program was: 95℃ pre-denaturation for 5 min; 95℃ for 10 sec → 58℃ for 20 sec → 72℃ for 20 sec, for 40 cycles. Data calculation: using 2 -ΔΔCt The relative expression level of MyHC mRNA was analyzed using a method (with β-actin as an internal reference).

[0157] 2.4 Statistical Analysis

[0158] Experimental data were statistically analyzed using SPSS 26.0 software. Quantitative data were expressed as mean ± standard deviation (Mean ± SD). One-way ANOVA was used for comparisons between groups. P < 0.05 was considered statistically significant.

[0159] 3. Experimental Results

[0160] The mRNA expression level of the MyHC gene in C2C12 cells was detected by real-time quantitative PCR. The effects of different traditional Chinese medicine compositions (groups 1–27) containing the drug in serum on its expression were analyzed. The results are shown in the figure. Compared with the model group, the differences between groups 1–27 were marked with "*", *P<0.05, ***P<0.001.

[0161] The experimental results showed that groups 11, 20, and 27 all exhibited significantly higher MyHC expression levels compared to the model group, with group 20 showing the best therapeutic effect. This suggests that the three traditional Chinese medicine combinations mentioned above may have potential advantages in promoting the expression of muscle differentiation marker genes, warranting further investigation. The remaining combinations did not show significant promoting effects, and some combinations even showed expression levels lower than the model group, indicating significant differences in the regulatory effects of different drug combinations on MyHC expression. (Results are as follows...) Figure 1 As shown.

[0162] Example 2 of efficacy

[0163] Using a composite model and evaluation index combining the preparation example and the efficacy example, the efficacy of the above-mentioned drug composition in group 20 for treating sarcopenia was further verified.

[0164] 1. Experimental Materials

[0165] 1.1 Laboratory Animals

[0166] Six-month-old male SAMP8 mice were used as the model animals, and SAMR1 mice were used as negative control animals. They were purchased from Spiefolk (Beijing) Biotechnology Co., Ltd. All mice were housed individually in a temperature- and humidity-controlled animal room. The temperature was maintained at (24±1)℃, and the relative humidity was 50%–70%. The light-dark cycle was 12 hours. Mice had free access to standard feed and drinking water. All experimental procedures were strictly conducted in accordance with animal ethics regulations. Based on previous studies, SAMP8 mice enter the pre-sarcopenia stage at 8 months of age and exhibit typical sarcopenia symptoms at 10 months of age. Therefore, SAMP8 mice were raised to 8 months of age before intervention was initiated during the experimental period.

[0167] 1.2 Experimental Drugs

[0168] Group 20 consisted of the herbal composition obtained from the aforementioned preparation examples. Based on body surface area, the equivalent human dose was calculated, resulting in three dosage groups: low (4.94 g / kg), medium (9.88 g / kg), and high (19.76 g / kg). The drug was dissolved in ultrapure water and administered by gavage. The control and model groups received the same volume of distilled water.

[0169] 1.3 Experimental Grouping

[0170] Thirty-two 8-month-old SAMP8 mice were randomly divided into four groups: a model group, a low-dose group, a medium-dose group, and a high-dose group, with eight mice in each group. Eight age-matched SAMR1 mice were used as a negative control group. Mice in each group were administered the drug via gavage once daily for eight weeks. The gavage volume was uniformly 0.1 mL / 10g body weight.

[0171] 2. Experimental Methods

[0172] 2.1 Weight monitoring

[0173] Mouse weight was recorded weekly during the intervention period.

[0174] 2.2 Muscle mass testing

[0175] Eight weeks after intervention, the mice were sacrificed, and the quadriceps, gastrocnemius, tibialis anterior, extensor digitorum longus, and soleus muscles were dissected and weighed. The skeletal muscle mass index (i.e., the proportion of skeletal muscle mass to body weight) was calculated to assess the change in total skeletal muscle mass.

[0176] 2.3 Mouse muscle function test

[0177] 2.3.1 Grip Test

[0178] The maximum gripping force (in N) of mice during the process of gently pulling on the tail until the grip is released was recorded using a mouse grip strength meter (Jiangsu Saions Biotechnology Co., Ltd.). Each mouse was tested three times, and the average value was taken and normalized according to body weight.

[0179] 2.3.2 Running Exhaustion Experiment

[0180] Testing was conducted 3 days after training. An electric treadmill (Anhui Zhenghua Biological Instrument Equipment Co., Ltd.) was used, with an initial speed of 10 m / min. After 2 minutes of running, the speed was increased by 2 m / min every 2 minutes, eventually reaching 20 m / min. Mice were considered exhausted when they remained in the tail area where they received the electric shock for 10 consecutive seconds without running. Their total running time and distance were recorded.

[0181] 2.3.3 Rotating Rod Experiment

[0182] Formal testing was conducted after 3 days of training and adaptation. A rotarod apparatus (Anhui Zhenghua Biological Instrument Equipment Co., Ltd.) was used, with the rotation speed gradually increased from 4 rpm to 40 rpm and maintained. The dwell time on the rotarod and the rotation speed at the time of fall for each mouse were recorded.

[0183] 2.3.4 Suspension Test

[0184] Mice were placed in the center of an inverted wire mesh (Shanghai Yuyan Scientific Instruments Co., Ltd.), and the time taken from the start of suspension to the fall was recorded, with the "suspension index" normalized to body weight used as the indicator.

[0185] 2.4 Histological Analysis

[0186] After euthanizing the mice, the gastrocnemius muscle was harvested, fixed with muscle fixative, embedded in paraffin, sectioned, and stained with hematoxylin and eosin (HE) and Masson's stain. The morphology of the muscle fibers was observed under a microscope, and the cross-sectional area (CSA) of the muscle fibers and the volume fraction of collagen fibers were measured using ImageJ image analysis software.

[0187] 2.5 Statistical Methods

[0188] Experimental data were statistically analyzed using SPSS 26.0 software. Quantitative data were expressed as mean ± standard deviation (Mean ± SD). One-way ANOVA was used for comparisons between groups. P < 0.05 was considered statistically significant.

[0189] 3. Experimental Results

[0190] 3.1 Changes in mouse body weight

[0191] The results are as follows Figure 2 As shown, before the intervention, there was no statistically significant difference in body weight among the SAMP8 mice in each group, indicating that the experimental system was stable and reliable and the groups were comparable. During the experiment, the body weight of the model group mice continued to decrease, exhibiting typical signs of sarcopenia. The body weight of the control group mice increased slightly in the early stage and then stabilized in the later stage. In the drug intervention groups, the body weight of the high-dose group mice gradually increased, and by week 8 it was significantly higher than that of the model group; although the low- and medium-dose groups also showed an increasing trend, the difference was not statistically significant. The body weight of the negative control group was significantly different from that of the model group. The above results suggest that the drug composition of group 20, under high-dose intervention conditions, can effectively slow down the body weight loss of sarcopenic mice and improve their overall nutritional and physiological status.

[0192] 3.2 Skeletal muscle mass

[0193] The results are as follows Figure 3 , Figure 4As shown, after 8 weeks of intervention, significant differences were observed in muscle mass across multiple skeletal muscles (quadriceps, gastrocnemius, tibialis anterior, extensor digitorum longus, and soleus) in each group of mice. Specifically, the model group showed significantly lower muscle mass in all five muscles compared to the control group, indicating a successful establishment of the sarcopenia model. Compared to the model group, the low, medium, and high dose groups all showed statistically significant differences in the quadriceps and tibialis anterior muscles; significant increases in the gastrocnemius, extensor digitorum longus, and soleus muscles were also observed in the high dose group. These results suggest that the drug composition in Group 20 has a good muscle-building effect, demonstrating potential application value in intervening in the progression of sarcopenia.

[0194] 3.3 Muscle Function

[0195] The results are as follows Figure 5 As shown, the grip strength test results indicated that the grip strength of mice in the medium and high dose groups was significantly better than that in the model group; further, after standardization to body weight (grip strength index), the grip strength index of the medium and high dose groups was also significantly higher than that of the model group, indicating that the drug composition in group 20 has a good effect on improving muscle strength. The results are as follows... Figure 6 As shown, the exercise endurance performance of mice was assessed using a run-to-exhaustion test. After 8 weeks of intervention, compared with the model group, the pre-exhaustion running distance and running time of mice in the medium-dose and high-dose groups were significantly prolonged, with statistically significant differences, suggesting that the drug composition has an effect on improving exercise endurance. Results are as follows... Figure 7 As shown, in the rotator experiment, the high-dose group significantly outperformed the model group in both rotator dwell time and maximum rotator speed, indicating a positive effect on improving coordination and balance. The results are as follows... Figure 8 As shown, in the grid suspension experiment, there were no statistically significant differences in the original suspension time among the groups. However, after weight standardization, the suspension times of the medium-dose and high-dose groups were significantly better than those of the model group, further supporting the potential effect of the drug composition on counteracting myasthenia gravis. In summary, the drug composition in group 20 showed a significant improvement trend in multiple functional indicators, especially in improving exercise endurance, muscle strength, and balance coordination.

[0196] 3.4 Histological Analysis

[0197] HE staining is used to observe changes in muscle tissue structure and to measure the cross-sectional area of ​​muscle fibers (CSA) (results are shown in Figure 1). Figure 9(As shown). After 8 weeks of intervention, compared with the model group, the cross-sectional area of ​​muscle fibers in mice in the low, medium, and high dose groups was significantly increased, suggesting that the drug composition in group 20 can effectively slow down muscle fiber atrophy and improve muscle structure. Masson staining results showed that compared with the model group, the volume fraction of collagen fibers in the muscles of mice in the medium and high dose groups was significantly reduced, suggesting that the degree of fibrosis was reduced and the muscle tissue structure was significantly repaired. Although the low dose group showed a certain improvement trend, the difference was not statistically significant (results are shown in figure). Figure 10 (As shown). The above results indicate that the drug composition in group 20 can significantly improve muscle atrophy and fibrosis at the tissue morphology level, further verifying its tissue protective effect against sarcopenia.

[0198] 4. Experiment Summary

[0199] In summary, there is currently a lack of systematic and effective traditional Chinese medicine (TCM) intervention programs for sarcopenia in the elderly. Based on the TCM pathogenesis of "spleen and kidney deficiency, and insufficient qi and blood," and combining years of clinical experience with modern research findings, the inventors have innovatively proposed a treatment approach of "tonifying qi and nourishing blood, strengthening the spleen and benefiting the kidneys," and constructed a TCM compound formula with Polygonatum sibiricum as the principal ingredient—the Polygonatum Nourishing Muscle Formula. This formula is meticulously formulated, with clear distinctions between the principal, assistant, and adjuvant herbs, ensuring that the medicine matches the symptoms and that the dosage is synergistic, forming a scientifically sound intervention system that provides a systematic solution for the etiology and manifestations of sarcopenia.

[0200] This invention uses a uniform design method to screen for the optimal drug combination and conducts systematic efficacy verification using in vitro cell models and in vivo SAMP8 mouse models. The results show that the drug composition can effectively improve muscle strength, muscle mass, exercise endurance, grip strength, and coordination in the model animals, and improve muscle structure and fibrosis status, demonstrating good anti-sarcopenia effects and promising clinical application prospects.

[0201] This invention not only establishes a clear pharmacological mechanism, but also integrates traditional formulation wisdom with modern experimental methods, providing a reproducible, evaluable, and scalable technical solution for traditional Chinese medicine intervention in sarcopenia in the elderly.

[0202] The embodiments of the present invention have been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of the present invention. The descriptions of the embodiments above are only for the purpose of helping to understand the method and core ideas of the present invention. Furthermore, any changes or modifications made by those skilled in the art based on the ideas of the present invention, its specific implementation methods, and its application scope, are all within the scope of protection of the present invention. Therefore, the content of this specification should not be construed as a limitation of the present invention.

Claims

1. A composition comprising Polygonatum for the prevention and / or treatment of sarcopenia, characterized in that, The composition is made from Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida; The mass ratio of the following ingredients is (9.5–10.5):(5.7–6.3):(14.25–15.75):(8.55–9.45):(8.55–9.45):(11.4–12.6):(11.4–12.6):(8.55–9.45), or (14.25–15.75):(5.7–6.3). ): (9.5~10.5): (8.55~9.45): (8.55~9.45): (11.4~12.6): (8.55~9.45): (5.7~6.3), or (14.25~15.75): (11.4~12.6): (14.25~15.75): (11.4~12.6): (5.7~6.3): (11.4~12.6): (8.55~9.45): (8.55~9.45).

2. The composition according to claim 1, characterized in that, The weight of the Polygonatum is 9.5g to 10.5g or 14.25g to 15.75g.

3. The composition according to claim 1, characterized in that, The weight of the Angelica sinensis is 5.7g to 6.3g or 11.4g to 12.6g.

4. The composition according to claim 1, characterized in that, The weight of the Codonopsis pilosula is 9.5g to 10.5g or 14.25g to 15.75g.

5. The composition according to claim 1, characterized in that, The weight of the prepared Rehmannia root is 8.55g to 9.45g or 11.4g to 12.6g.

6. The composition according to claim 1, characterized in that, The weight of the Cistanche deserticola is 5.7g to 6.3g or 8.55g to 9.45g.

7. The composition according to claim 1, characterized in that, The weight of the goji berries is 11.4g to 12.6g.

8. The composition according to claim 1, characterized in that, The weight of the Poria cocos is 8.55g to 9.45g or 11.4g to 12.6g.

9. The composition according to claim 1, characterized in that, The weight of the hawthorn is 5.7g to 6.3g or 8.55g to 9.45g.

10. A method for preparing the composition according to any one of claims 1 to 9, characterized in that, The preparation method includes the following steps: (1) Weigh out Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos and Crataegus pinnatifida. Add water for the first time, soak and heat to extract. After boiling, continue to decoct for a period of time, filter to obtain the first filtrate and the first dregs. (2) Add water to the first dregs for the second time and heat to extract. After boiling, continue to decoct for a period of time, filter, and obtain the second filtrate. as well as (3) The first filtrate and the second filtrate are combined, concentrated into a concentrated solution, and then dried to obtain the composition.

11. The preparation method according to claim 10, characterized in that, The water is distilled water or ultrapure water.

12. The preparation method according to claim 10, characterized in that, The soaking time is 0.5 to 2 hours.

13. The preparation method according to claim 10, characterized in that, The ratio between the mass of the water added in the first addition and the total mass of the Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida is 1 to 20.

14. The preparation method according to claim 13, characterized in that, The ratio between the mass of the water added in the first addition and the total mass of the Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida is 9.5 to 10.

5.

15. The preparation method according to claim 10, characterized in that, The ratio between the mass of the water added in the second addition and the mass of the first dregs or the total mass of the Polygonatum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida is 1 to 20.

16. The preparation method according to claim 15, characterized in that, The ratio between the mass of the water added in the second addition and the mass of the first dregs or the total mass of the Polygonatum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos and Crataegus pinnatifida is 7.6 to 8.

4.

17. The preparation method according to claim 10, characterized in that, In step (1), the boiling and simmering time is 0.5 to 2 hours.

18. The preparation method according to claim 17, characterized in that, The boiling and subsequent simmering time is 0.95 to 1.05 hours.

19. The preparation method according to claim 10, characterized in that, In step (2), the boiling and simmering time is 0.3 to 1 hour.

20. The preparation method according to claim 19, characterized in that, The boiling and subsequent simmering time is 0.475–0.525 h.

21. The preparation method according to claim 10, characterized in that, The drying temperature is 50–70°C.

22. The preparation method according to claim 21, characterized in that, The drying temperature is 57–63°C.

23. A pharmaceutical preparation, characterized in that, The pharmaceutical preparation comprises the composition of any one of claims 1 to 9, and one or more pharmaceutically acceptable excipients.

24. The pharmaceutical preparation according to claim 23, characterized in that, The excipients are selected from one or more of the following: diluents, wetting agents, adhesives, disintegrants, encapsulating agents, flavoring agents, sustained-release agents, flow aids, lubricants, dispersants, plasticizers, opacifiers, and antioxidants.

25. The pharmaceutical preparation according to claim 23, characterized in that, The dosage form of the pharmaceutical preparation is powder, tablet, drop pill, capsule, film, lozenge, granule, injection or oral liquid.

26. Use of a composition of any one of claims 1 to 9 or a pharmaceutical preparation of any one of claims 23 to 25 in the preparation of a medicament for the prevention and / or treatment of sarcopenia.

27. The use according to claim 26, characterized in that, The composition or the preparation prevents and / or treats sarcopenia through one or more of the following mechanisms: increasing MyHC gene mRNA expression levels, increasing body weight, increasing muscle mass, improving muscle motor function, and improving muscle pathological abnormalities.

28. The use according to claim 27, characterized in that, The muscle mass includes the mass of the quadriceps femoris, gastrocnemius, tibialis anterior, extensor digitorum longus, and / or soleus.

29. The use according to claim 27, characterized in that, The improvement in muscle function includes increased physical endurance, increased muscle strength, and / or improved balance and coordination.

30. The use according to claim 27, characterized in that, The muscle pathological abnormalities include muscle fiber atrophy and / or muscle fibrosis.

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